If you are seeing wet loads in your autoclave we can help, this presentation helps show what a wet load is and why its important. It also includes some of the potential root causes of wet loads.
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EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Dev...Pacific BioLabs
This presentation provides important details on how to save time and money in the process of reusable medical device design. The main focus is on how device material choice and design affects the cleaning and disinfection process, and what considerations design engineers need to make when creating reusable medical devices.
Colder Products Company-Aseptic Connections for Single Use ApplicationsLynzee Perdaris
Single Use Technology Integration with Aseptic Connections to Meet Sterility, Dependability, Quality and Traceability! For more information contact Lynzee Perdaris at lperdaris@stiflow.com.
Guidance on gloves maintenance in Isolator and RABSPalash Das
A faulty glove or sleeve assembly represents a route of contamination and a critical breach of Isolator integrity. Within this article we will discuss about all these aspects.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Dev...Pacific BioLabs
This presentation provides important details on how to save time and money in the process of reusable medical device design. The main focus is on how device material choice and design affects the cleaning and disinfection process, and what considerations design engineers need to make when creating reusable medical devices.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Refractive window drying - a novel technologyMahesh Khatri
refractive window drying is a novel technology which can be use to dry the semi solid, puree and paste type of product. the advantage of this drying technology, its minimising drying time, and provides better quality product with higher retention of nutrients in comparison with other conventional drying techniques.
Validation & Verification Study for Metal Detection CCP - AG - LinkedIn profi...Adrian Garcia
This project contains an example of a validation and verification study for 3 models of metal detectors posed as an alternative to replace current aging models in current food manufacturing lines.
This is a Validation & Verification for BRC Global Standards Course Assignment, MAR 2022
Done by Creators group, Karaana Independent secondary school for boys
Food packaging is packaging for food. A package provides protection, tampering resistance, and special physical, chemical, or biological needs.
Now lots of products are made out of plastic. A lot of it is throw away and will stay in garbage dumps of thousands of years. Biodegradable plastic, unlike normal plastic made from petroleum, will decompose and become part of the soil. This project will show how one easy way to make some biodegradable plastic that can be used in food packaging and thus become edible
CIP vs COP - Hygienic Pumps and Meeting Government Regulations - Carotek Proc...Carotek
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This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinmüller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R.
Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
This presentation looks at superheat in porous load autoclaves. It explains what superheat is, why superheat is a problem and identifies the causes superheat.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Refractive window drying - a novel technologyMahesh Khatri
refractive window drying is a novel technology which can be use to dry the semi solid, puree and paste type of product. the advantage of this drying technology, its minimising drying time, and provides better quality product with higher retention of nutrients in comparison with other conventional drying techniques.
Validation & Verification Study for Metal Detection CCP - AG - LinkedIn profi...Adrian Garcia
This project contains an example of a validation and verification study for 3 models of metal detectors posed as an alternative to replace current aging models in current food manufacturing lines.
This is a Validation & Verification for BRC Global Standards Course Assignment, MAR 2022
Done by Creators group, Karaana Independent secondary school for boys
Food packaging is packaging for food. A package provides protection, tampering resistance, and special physical, chemical, or biological needs.
Now lots of products are made out of plastic. A lot of it is throw away and will stay in garbage dumps of thousands of years. Biodegradable plastic, unlike normal plastic made from petroleum, will decompose and become part of the soil. This project will show how one easy way to make some biodegradable plastic that can be used in food packaging and thus become edible
CIP vs COP - Hygienic Pumps and Meeting Government Regulations - Carotek Proc...Carotek
Learn about the recent trends and legislation that impacts COP vs CIP in the food & beverage processing and pharmaceutical markets. Learn what to look for in equipment selection to maximize process efficiency and flexibility, while meeting hygienic requirements.
This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinmüller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R.
Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
This presentation looks at superheat in porous load autoclaves. It explains what superheat is, why superheat is a problem and identifies the causes superheat.
Fire, Pressure & Ice – Oh My! Motion Control in Hostile EnvironmentsDesign World
Some of the most challenging and rewarding motion control applications are not made difficult because of the complexity of the machine but rather due to the hostile environments in which the application must succeed. From arctic conditions in biomedical cryogenic laboratories to the low pressure, high altitude skies that most commercial aircrafts operate, learning the particular nuances of harsh environments is a necessity to many manufacturers, machine builders, and system integrators.
Join Hack Summer of Moog Animatics as we explore some of the common (and most underestimated) hostile environments for motion control applications. Get application examples along with expert tips for designing motion control systems for hostile environments, a brief first look at Moog Animatics’ new extended range integrated motion control systems and best practices learned from over 20 years’ experience in military and commercial motion control design.
Watch this webinar to learn:
- What explosion proof really means for motion control systems?
- Which hostile environments benefit from integrated motion control systems vs. conventional motion control systems?
- Why temperature isn’t the biggest concern for aerospace applications – and what is?
- What questions to ask when buying ‘extended temperature range’ products?
Malfunctions in Solar Thermal InstallationsSekem Energy
Solar Thermal Conference "Paving ways together for solar thermal energy in Egypt" at Heliopolis University, Cairo, on 18th May 2016
"Most common malfunctions of solar thermal systems", Mr. Markus Reischl, Solarexpert
Design Calculation of Venting for Atmospheric & Low Pressure Storage TanksKushagra Saxena
Storage Tanks are a very important part of a petroleum Industry, This software is based on the API Std. 2000, which calculates the design of Venting and its capacity for low pressure storage & atmospheric storage tanks in case of normal venting, due to thermal changes, and in case of fire exposure.
If you are in need of this software, Kindly contact at saxena.95kushagra@gmail.com
1. Heating And Cooling In Regina, Canada
2. Heating and Cooling Specialists Information
3. Having Your Furnace Inspected
4. Furnace Repair in Regina, Canada
5. When You are in Need of Furnace Repairs
6. Furnace Inspection Is a Necessity
Sterilization.pdf Sterilization is the complete destruction of microorganisms...Talal Albudayri
Introduction
Sterilization is the complete destruction of
microorganisms including bacterial spores. This level
of decontamination is required for all reusable
invasive medical devices (RMD).
Ideally, sterilization methods:
• Have rapid throughput
• Are easily validated
• Are capable of processing wrapped items to
enable storage after processing without the risk of
environmental contamination of processed items.
CW RADAR, FMCW RADAR, FMCW ALTIMETER, AND THEIR PARAMETERSveerababupersonal22
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Terzaghi's soil bearing capacity theory, developed by Karl Terzaghi, is a fundamental principle in geotechnical engineering used to determine the bearing capacity of shallow foundations. This theory provides a method to calculate the ultimate bearing capacity of soil, which is the maximum load per unit area that the soil can support without undergoing shear failure. The Calculation HTML Code included.
Immunizing Image Classifiers Against Localized Adversary Attacksgerogepatton
This paper addresses the vulnerability of deep learning models, particularly convolutional neural networks
(CNN)s, to adversarial attacks and presents a proactive training technique designed to counter them. We
introduce a novel volumization algorithm, which transforms 2D images into 3D volumetric representations.
When combined with 3D convolution and deep curriculum learning optimization (CLO), itsignificantly improves
the immunity of models against localized universal attacks by up to 40%. We evaluate our proposed approach
using contemporary CNN architectures and the modified Canadian Institute for Advanced Research (CIFAR-10
and CIFAR-100) and ImageNet Large Scale Visual Recognition Challenge (ILSVRC12) datasets, showcasing
accuracy improvements over previous techniques. The results indicate that the combination of the volumetric
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Using recycled concrete aggregates (RCA) for pavements is crucial to achieving sustainability. Implementing RCA for new pavement can minimize carbon footprint, conserve natural resources, reduce harmful emissions, and lower life cycle costs. Compared to natural aggregate (NA), RCA pavement has fewer comprehensive studies and sustainability assessments.
We have compiled the most important slides from each speaker's presentation. This year’s compilation, available for free, captures the key insights and contributions shared during the DfMAy 2024 conference.
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Water billing management system project report.pdfKamal Acharya
Our project entitled “Water Billing Management System” aims is to generate Water bill with all the charges and penalty. Manual system that is employed is extremely laborious and quite inadequate. It only makes the process more difficult and hard.
The aim of our project is to develop a system that is meant to partially computerize the work performed in the Water Board like generating monthly Water bill, record of consuming unit of water, store record of the customer and previous unpaid record.
We used HTML/PHP as front end and MYSQL as back end for developing our project. HTML is primarily a visual design environment. We can create a android application by designing the form and that make up the user interface. Adding android application code to the form and the objects such as buttons and text boxes on them and adding any required support code in additional modular.
MySQL is free open source database that facilitates the effective management of the databases by connecting them to the software. It is a stable ,reliable and the powerful solution with the advanced features and advantages which are as follows: Data Security.MySQL is free open source database that facilitates the effective management of the databases by connecting them to the software.
2. What isawetload?
• When an autoclave load is removed from the
chamber, the load must be dry. In moist
environments microbial growth can occur.
• Dryness is difficult to define though, so at
what level is any condensate acceptable?
At Thermal Compliance we define it as, if
condensate can be detected by the senses, it is
not acceptable. Therefore you must not:
• See it
• Feel it
3. Autoclave
Basic overview of how a Porous Load Steam Steriliser works
Steam pressure is controlled to ensure
the drain is the correct temperature.
Baffle plates force steam to displace air
down the drain.
Condensate will collect if not allowed to free drain.
4. Potential Causes
Wet loads can be caused by several factors:
Steam Distribution / Steam Quality Issues
• Failed Steam Traps
• Steam Generator Issues
Autoclave
• Jacket Temperature
• Vacuum Pump Issues
• Fans. Pipework on Roof of Chamber
Load Design and Preparation
• Change in Load Wrapping
• Load Item Materials of Construction
• Poor Load Orientation
• Poor Load Wrapping
5. Potential Causes
Steam Distribution / Steam Quality
Step 1
Perform Steam Quality Testing (EN285:2015, PDA Technical Report 1)
• At Point of Use
• At Point of Generation
Step 2
Perform a Distribution Survey
• Check Steam Traps
• Pipe levels etc
6. Potential Causes
Load Design and Preparation
Ensure the bags used for wrapping
are specified correctly, ensure they
are:
• The right size for your items
• The right shape for your items
Load Wrapping
Cut bags to Size
Use suitable Size bags
Don’t fold over bags
Remove Excess
Wrap
Orientate the load to:
• Allow free draining
• Place large items on the bottom
shelf
• Consider where condensate
would be generated and how to
remove it
Orientation of Load
Paper/Plastic Bags should be
orientated with paper adjacent to
paper and plastic adjacent to plastic.
Bag placement
7. Potential Causes
Autoclave
The Jacket temperature should be below
sterilisation temperature. To allow
condensate to form and go to drain.
High Temperatures may cause superheat
and low temperatures may cause
condensate to rain onto the load.
Vacuum Pump
Check feed water temperature
Check pulse times and depths.
Does the wet load
correlate to ports, fans etc
in the Autoclave Roof?
8. 0201
ABOUT US
We deliver practical and online
training courses in:
• Autoclave Validation
• Temperature Mapping
• Steam Quality Testing
• Kaye Validator 2000
Training
We can help with:
• Wet Loads
• Superheat Investigations
• Equilibration Failures
• Steam Quality Failures
• Biological Indicator Failures
Consultancy 03We perform Validation on a
wide range of equipment:
• LN2 Freezers – Ovens
• Autoclaves and SIP
• Freeze Driers
• Dry Heat Processes
Validation
9. CONTACT US
Chris Maughan
Managing Director
Thermal Compliance
chrism@thermalcompliance.co.uk
www.thermalcompliance.co.uk
18 Harelands Courtyard Offices
Moor Road Melsonby
Richmond
DL10 5NY
UK
Tel +44 (0)1748 327 247
www.thermalcompliance.com
(Training Website)